PROSPECTO: INFORMATION FOR THE USER

Tanolux 50 micrograms/ml eye drops in solution in single-dose container

latanoprost

Read this prospect carefully before starting to use this medicine, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, or the doctor treating your child, or the pharmacist.
• This medicine has been prescribed only to you or your child and should not be given to other people, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor, or the doctor treating your child, or the pharmacist, even if they do not appear in this prospect. See section 4.

Content of the prospect:

1. What Tanolux is and for what it is used
2. What you need to know before starting to use Tanolux
3. How to use Tanolux
4. Possible adverse effects
5. Storage of Tanolux
6. Contents of the container and additional information

Latanoprost belongs to a group of medications known as prostaglandin analogs. It works by increasing the natural drainage of fluid from the inside of the eye to the bloodstream.

Latanoprost is used to treat certain diseases known asopen-angle glaucoma and ocular hypertensionin adults. Both diseases are related to an increase in pressure within the eye, which can potentially affect vision.

Latanoprost is also used to treat increased pressure within the eye and glaucoma in children and infants of all ages.

Latanoprost may be used in adult men and women (including elderly) and in children from birth to 18 years of age. Latanoprost has not been investigated in premature children (less than 36 weeks of gestation).

Do not use Tanolux

• If you are allergic (hypersensitive) to latanoprost or to any of the other components of this medication (listed in section 6).

Warnings and precautions

If you consider that any of the following situations affect you or your child, consult your doctor, or the doctor treating your child, or the pharmacist before using Tanolux or before administering it to your child:

• If you or your child have undergone or are going to undergo eye surgery (including cataract surgery).
• If you or your child have eye problems (such as eye pain, irritation, or inflammation, blurred vision).
• If you or your child have dry eyes.
• If you or your child have severe asthma or asthma that is not well controlled.
• If you or your child use contact lenses. They may continue to use Tanolux, but they must follow the instructions included in section 3 for contact lens users.
• If you have suffered or are suffering from a viral eye infection caused by the herpes simplex virus (HSV).

Use of Tanolux with other medications

Tanolux may interact with other medications. Inform your doctor, the doctor treating your child, or the pharmacist if you or your child are using or have recently used other medications (or eye drops), including those purchased without a prescription. In particular, consult your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogs, or prostaglandin derivatives.

Pregnancy and breastfeeding

You should not use Tanoluxif you are pregnant or breastfeeding unless your doctor considers it necessary. If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

When using Tanolux, blurred vision may appear for a short period of time. If this happens,do not driveor use tools or machinery until your vision returns to normal.

Tanolux contains benzalkonium chloride and phosphate buffers

This medication contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride may be absorbed by soft contact lenses and may change the color of the contact lenses. Remove your contact lenses before using this medication and reinsert them 15 minutes later.

Benzalkonium chloride may also cause eye irritation, especially if you have dry eyes or corneal disorders (the transparent front part of the eye). If you experience unusual sensations in your eyes, burning, or eye pain after using this medication, consult your doctor.

This medication contains 6.3 mg/ml of phosphates, equivalent to 0.2 mg/drop.

If you suffer a severe injury to the transparent front part of the eye (the cornea), phosphates may cause, in rare cases, cloudy areas in the cornea due to calcium deposits produced during treatment.

Follow exactly the administration instructions for Tanolux indicated by your doctor, or by the doctor treating your child. Consult your doctor, or the doctor treating your child, or the pharmacist if you have any doubts.

The recommended dose for adults (including elderly) and children is one drop in the eye or in the affected eyes once a day. It is preferable to administer it at night.

Do not use Tanolux more than once a day; the effectiveness of the treatment may decrease if administered more frequently.

Use Tanolux as your doctor or the doctor treating your child has instructed you to, until they tell you to stop.

Users of contact lenses

If you or your child use contact lenses, you must remove them before using Tanolux. After applying Tanolux, wait 15 minutes before putting the contact lenses back in.

Instructions for use

Wash your hands before using it. Make sure the single-use vial is intact before using this medication. The solution must be used immediately after opening the vial. To avoid contamination, do not let the tip of the single-use vial touch the eye or any other surface.

1,2, 3. Take a single-use vial from the bag and hold it in a vertical position (with the cap facing up) and turn the cap until it comes off.

4. Gently pull the lower eyelid down to form a pocket. Invert the single-use vial and press until a drop falls into the eye or eyes affected.

5. Dispose of the single-use vial after use, even if there is solution left inside.

Using Tanolux with other eye drops

Wait at least 5 minutes between applying Tanolux and administering other eye drops.

Using more Tanolux than you should

If more drops than you should have been applied to the eye, you may feel a slight irritation in the eye and the eyes may become red and tearful; this situation should resolve, but if you are concerned, contact your doctor or the doctor treating your child.

In case of accidental ingestion by you or your child, consult your doctor or pharmacist as soon as possible, or call the Toxicological Information Service, phone: 91 562 04 20.

Missing a dose of Tanolux

Continue with the administration of the next dose in the usual manner. Do not apply an additional drop to the eye to compensate for the missed dose. If you have any doubts, consult your doctor or pharmacist.

Stopping treatment with Tanolux

If you want to stop using Tanolux, consult your doctor or the doctor treating your child.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following are known side effects when using Tanolux:

Frequent side effects(may affect more than 1 in 10 patients):

Common side effects(may affect up to 1 in 10 patients):

Uncommon side effects(may affect up to 1 in 100 patients):

Rare side effects(may affect up to 1 in 1,000 patients):

Very rare side effects(may affect up to 1 in 10,000 patients):

The side effects observed in children at a frequency greater than in adults are runny nose and nasal itching and fever.

In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits produced during treatment.

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Communication of side effects:

If you experience any type of side effect, consult your doctor, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

This medication does not require any special storage temperature.

Medications should not be disposed of through drains or in the trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of packaging and unused medications. By doing so, you will help protect the environment.

The active ingredient is latanoprost 50 micrograms/ml.

The other components are: benzalkonium chloride, sodium chloride, sodium dihydrogen phosphate monohydrate (E339i), anhydrous sodium hydrogen phosphate (E339ii), and water for injection preparations.

Appearance of the product and contents of the packaging

Tanolux eye drops is a transparent and colorless liquid that is supplied in single-dose plastic containers, each containing 0.4 ml of solution.

The box contains 3, 6, 9 aluminum bags, each with 10 single-dose containers, with a total of 30, 60, 90 single-dose containers in the box respectively.

Only some sizes of containers may be commercially marketed.

Holder of the marketing authorization

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Responsible for manufacturing

Pharmaloop S.L.

C/Bolivia, 15 – Polig Industrial Azque

28806 Alcalá de Henares,

Madrid – Spain

Laboratorios Salvat, S.A.

Gall, 30-36 - 08950

Esplugues de Llobregat (Barcelona)

Spain

Last review date of this leaflet: January 2023

This medicine is authorized in the member states of the European Economic Area with the following names:

SpainTanolux 50 micrograms/ml eye drops in solution in single-dose container

PortugalTanolux 0.02 mg/ 0.4 ml eye drops, solution in single-dose container

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/